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investinthefuture

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investinthefuture

Re: frequent1 post# 72757

Sunday, 07/08/2018 1:20:26 PM

Sunday, July 08, 2018 1:20:26 PM

Post# of 140464
Watch the AGM video. It better explains the current timeline for design freeze and regulatory approval. In short, the FDA is requesting confirmatory studies in humans to demonstrate predicate device equivalence. That stretches out the timeline when compared to a regulatory pathway with porcine- and cadaveric-only studies.
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